The invention relates generally to diagnostic devices that are positionable on a penis and usable to identify physiological male impotency from psychological male impotency. More particularly, the invention concerns a novel plural-characteristic-measuring radial erectometer that is constructed for radially measuring plural characteristics of a penile erection, such as penile rigidity and penile tumescence.
Male impotency may occur for either of two basic reasons, a physiological one, or a psychological one. In other words there are two types, "psychological impotency" and "physiological impotency". To treat impotency in a given patient, one must first determine which of the two reasons is the cause for that condition. For obvious reasons, it should be understood that following references to "patient" means a male one.
A known, convenient way to distinguish between the two types of impotency is to observe whether the patient has nocturnal erections in his sleep. Based on various research studies normal males regularly have such sleep erections. Certain research shows that they have approximately two to five such erections per night, depending on a variety of factors including age.
Males with psychological impotency also have such sleep erections. However, males with physiological impotency do not because, due to their particular condition, their bodies cannot achieve an erection at any time.
By reliably observing whether a patient has a sleep erection, one can determine whether he has psychological or physiological impotency. Essentially, if he has a sleep erection, the treating physician knows that the patient's impotency is of the psychological, not physiological type.
Various treatment methods have been developed for identifying whether a patient has a sleep erection. The essential problem is that a patient does not know he is having a sleep erection because it occurs in his sleep, usually his deepest sleep. Early on, conventional treatment involved expensive and undesirable direct observation of a patient during his sleep. The treatment was expensive because it involved hospital stay, and it was undesired because patients did not appreciate its non-private nature.
Some years ago, the first named inventor in the present application was involved with a substantial development in impotency treatment when he and certain colleagues invented the so-called stamp test which involved placing around a patient's flaccid penis a closed ring of stamps, like postage stamps, joined seriatim by perforated regions. The patient could wear such a device at home during his sleep. If he awoke to find the closed ring of stamps was broken open, he knew he had a sleep erection.
Since the invention of the stamp test, there have been numerous conventional proposals for improving and refining the basic test. One refinement involves constructing a device that provides more information than simply that a sleep erection has occurred. For example, the treating physician can also make use of information relating to the character of the sleep erection. There are at least two features of a sleep erection that are useful to the treating physician, one is known as the rigidity of the erection, and the other is known as the tumescence, or increase in circumference, of the penis.
Various conventional proposals have focused on either measuring rigidity or tumescence, but not both. For example, there is an impotency screening device sold by Dacomed Corporation under the trademark SNAP-GAUGE that measures penile rigidity. That device includes a plastic ring that is closed around a patient's flaccid penis. The device is formed with certain plastic elements, each of which will break if a sleep erection having a preselected degree of rigidity occurs.
Representative devices that measure penile tumescence are shown in U.S. Pat. Nos. 4,960,131 to Koss, 4,700,715 to Levine et al., and 4,428,385 to Morales. Each of these devices includes a closed ring fittable around a patient's flaccid penis, and each includes a particular mechanism for measuring tumescence. Those particular mechanisms include an expandable web portion of a ring (Levine et al.), a slider member constructed to allow a portion of a band to be pulled through it (Koss), and a plastic radially expansible loop made with a flexible tube open at ,me end for receiving a tail portion (Morales).
There has been one conventional proposal involving a device for measuring tumescence and rigidity, and it is shown in U.S. Pat. No. 4,469,108 to Goldstein. Goldstein shows a device that includes two radially expansible rings interconnected longitudinally in a spaced relationship by two blades positioned parallel to each other. Each blade is positioned adjacent diametrically opposing locations along the diameter of each ring. Goldstein shows to measure tumescence by the increased radial expansion of the rings, and to measure rigidity by the increase in longitudinal spacing between the rings. Apparently, a sleep erection will cause the rings to move apart as the length of the penis increases. A ratchet-like mechanism of the device maintains the increased spacing of the rings corresponding to the erection, and the radially expansible rings are also constructed to stay in their erection-caused, radially-expanded position.
There are certain drawbacks to the device proposed by Goldstein. For example, its design for measuring rigidity as a function of penile length results in a relatively unwieldy device that is uncomfortable to wear. This drawback is substantial because devices for determining the occurrence of a sleep erection must be extremely comfortable due to their use on an extremely sensitive area of the male body. It is also not clear that measuring penile rigidity as a function of penile length is as useful to the treating physician as by measuring rigidity based on radial-penile forces that act on a closed ring positioned around the penis. Additional patient discomfort may be caused because the device proposed by Goldstein requires that most of the length of the penis will be covered, at least partially, by the device. Further patient-discomfort may be caused when and if the device falls off the patient when his penis returns to a flaccid condition after the sleep erection. The increased, fixed, cylinder-approximating size of the device corresponding to the erect penis will present further patient discomfort because it will be in the patient's way during his sleep. For example, it is likely the patient will roll on the device. When that happens, the device will cause patient discomfort because it will not collapse due to the device's fixed and enlarged condition.
Nowhere has there been shown or suggested to provide a comfortable, reliable device for determining the occurrence of a sleep erection that measures plural characteristics of that erection. Accordingly, it is a principal object of the present invention to provide such a device that overcomes the drawbacks of prior-art devices.
Another object is to provide such a device that provides for reliable, accepted methods of measuring both the rigidity and tumescence of an erect penis.
Yet another object is to provide such a device that is extremely comfortable to wear.
Another important object of the invention is to provide such a device that does not require positioning on a relatively large portion of the penis.
Yet another object is to provide such a device that measures both penile rigidity and tumescence as a function of radial-penile forces caused by the sleep erection.
Still another object is to provide such a device that is easily detachable from the penis after the latter returns to a flaccid condition following a sleep erection.
Yet another object is to provide such a device that is unobtrusive to the patient should it detach during sleep, either inadvertently or because it falls off after the penis returns to its post-sleep-erection, flaccid condition.
It is also an object of the invention to provide such a device that can be easily and cost-effectively manufactured.
In brief summary, one aspect of the invention includes a plural-characteristic-measuring radial erectometer to be worn by a male user. The erectometer includes elongate band-like structure positionable around the user's flaccid penis and constructed to form a closed loop having a desired circumference corresponding to such flaccid penis. Also included is first measurement structure associated with the band-like structure and being manually movable to a first configuration providing an indication that the penis is in a flaccid condition. The first measurement structure is also radially movable to a second configuration as a result of radial-penile forces that will occur when the penis becomes erect. Correlation between the first and second configuration provides an indication that the penis changed from a flaccid condition to an erect condition, and provides a measurement of a first characteristic of that erect condition. That first characteristic is preferably penile rigidity.
The erectometer of the present invention also includes second measurement structure associated with the band-like structure that is manually movable to a first configuration providing an indication that the penis is in the flaccid condition. Like the first measurement structure, the second one is also radially movable to a second configuration as a result of the radial-penile forces. Correlation between the first and second configuration provides an indication that the penis changed from such flaccid condition to an erect condition, and provides a measurement of a second characteristic of that condition. That second characteristic is preferably tumescence.
These and other objects and advantages of the invention will be more clearly understood from a consideration of the accompanying drawings and the following description of the preferred embodiment.